Reported Sep 12, 2012 · Terminated

V60 Ventilator, Continuous Ventilator, Model# V60, PN 1056490 Product Usage: The V60 Ventilator is an assist Ventilator…

Respironics California Inc.

High riskUsing this product could cause serious injury, illness or death — stop using it now.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: Respironics California Inc · 2271 Cosmos Ct · Carlsbad, CA · 92011-1517

Is this the product you have?

    • V60 Ventilator
    • Continuous Ventilator
    • Model# V60
  • PN 1056490 Product UsageThe V60 Ventilator is an assist Ventilator and is intended to augment patient breathing. It is intended for spontaneously breathing individuals
  • who require mechanical ventilationpatients with respiratory failure, respiratory insufficiency, or obstructive sleep apnea in a hospital or other institutional settings under the direction of a physician. The V60 Ventilator is intended to support pediatric patients weighing 20kg (44 Ibs) or greater to adult patients. It is also intended for intubated patients meeting the same selection criteria as the noninvasive applications. It is intended to be used by qualified medical professionals, such as physicians, nurses, and respiratory therapists
Lot codes and dates
  • Seria Numbers

    197 of 197 codes

    • 100026615
    • 100029321
    • 100029838
    • 100030462
    • 100030832
    • 100026808
    • 100029324
    • 100029841
    • 100030463
    • 100030833
    • 100026826
    • 100029325
    • 100029843
    • 100030464
    • 100030834
    • 100027107
    • 100029327
    • 100029845
    • 100030466
    • 100030836
    • 100027181
    • 100029328
    • 100029847
    • 100030468
    • 100030838
    • 100027189
    • 100029330
    • 100030043
    • 100030469
    • 100030840
    • 100027544
    • 100029334
    • 100030106
    • 100030471
    • 100030843
    • 100027660
    • 100029337
    • 100030107
    • 100030472
    • 100030844
    • 100027751
    • 100029455
    • 100030111
    • 100030473
    • 100030845
    • 100027870
    • 100029456
    • 100030112
    • 100030474
    • 100030847
    • 100027872
    • 100029459
    • 100030113
    • 100030475
    • 100030850
    • 100027875
    • 100029462
    • 100030115
    • 100030481
    • 100030977
Amount recalled
197 units total (116 in the US)

Where it was sold

  • Nationwide

Why it was recalled

Stop using this product now

Respironics is recalling the V60 ventilator because certain blower motor assemblies in the V60 ventilators may not meet specifications. Specifically, the impeller may not be properly seated on the blower motor shaft. This could subsequently cause the blower to cease functioning which would result in the failure of the V60 ventilator to deliver therapy to the patient due to the loss of ventilatio

Using this product could cause serious injury, illness or death — stop using it now.

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA device enforcement) notice

Notice updated Mar 22, 2013 · Data as of Sep 19, 5:24 PM UTC

RecallNow is not a government agency. Every fact on this page is published by the FDA, USDA or CPSC and links back to their notice.